Job Description
The Process Quality Engineer will be responsible for ensuring that all manufacturing processes meet the stringent quality standards required for Class III medical devices. This role involves developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory requirements and industry standards.
ResponsibilitiesDevelop and implement process validation protocols and reports (IQ, OQ, PQ) to ensure manufacturing processes are capable and compliant.Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address process-related quality issues.Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure product quality and compliance.Monitor and analyze process performance data to identify trends and areas for improvement.Lead process improvement initiatives to enhance product quality, reduce waste, and increase efficiency.Ensure compliance with FDA regulations and other applicable standards.Participate in internal and external audits, providing necessary documentation and support.Train and mentor production staff on quality standards and best practices.Essential SkillsQuality engineeringQuality assuranceSupplier qualityMedical Device QE backgroundQuality AssuranceSupplier/Manufacturing Quality SupportPPAPRoot cause analysisAuditMedical deviceCAPAQuality controlQuality managementISOPFMEA5+ years experienceAdditional Skills & QualificationsExperience in developing and implementing process validation protocols and reports (IQ, OQ, PQ)Ability to conduct root cause analysis and implement corrective and preventive actions (CAPA)Strong collaboration skills with cross-functional teamsExperience in monitoring and analyzing process performance dataLeadership in process improvement initiativesKnowledge of FDA regulations and other applicable standardsExperience participating in internal and external auditsAbility to train and mentor production staff on quality standards and best practicesPay and Benefits
The pay range for this position is $60.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Boulder,CO.
Application Deadline
This position is anticipated to close on Apr 25, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.